adzynma

Generic: apadamtase alfa

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name adzynma
Generic Name apadamtase alfa
Labeler takeda pharmaceuticals america, inc.
Dosage Form KIT
Manufacturer
TAKEDA PHARMACEUTICALS AMERICA, INC.

Identifiers & Regulatory

Product NDC 64764-145
Product ID 64764-145_675b72f9-d3f0-4afc-9023-7024ddfbfc30
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125795
Listing Expiration 2026-12-31
Marketing Start 2023-11-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64764145
Hyphenated Format 64764-145

Supplemental Identifiers

RxCUI
2670293 2670300 2670311 2670313

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name adzynma (source: ndc)
Generic Name apadamtase alfa (source: ndc)
Application Number BLA125795 (source: ndc)

Resolved Composition

Strengths
  • 5 ml
  • 500 iu
  • 10 ml
  • 1500 iu
  • 20 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (64764-145-05) * 1500 [iU] in 1 VIAL, SINGLE-DOSE (64764-135-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)
source: ndc

Packages (1)

64764-145-05 1 KIT in 1 CARTON (64764-145-05) * 1500 [iU] in 1 VIAL, SINGLE-DOSE (64764-135-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

ADZYNMA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "675b72f9-d3f0-4afc-9023-7024ddfbfc30", "openfda": {"rxcui": ["2670293", "2670300", "2670311", "2670313"], "spl_set_id": ["22728e96-efa0-46c1-bdd1-ad89a796d5e3"], "manufacturer_name": ["TAKEDA PHARMACEUTICALS AMERICA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (64764-145-05)  *  1500 [iU] in 1 VIAL, SINGLE-DOSE (64764-135-01)  *  5 mL in 1 VIAL, GLASS (64764-515-50)", "package_ndc": "64764-145-05", "marketing_start_date": "20231109"}], "brand_name": "ADZYNMA", "product_id": "64764-145_675b72f9-d3f0-4afc-9023-7024ddfbfc30", "dosage_form": "KIT", "product_ndc": "64764-145", "generic_name": "Apadamtase Alfa", "labeler_name": "TAKEDA PHARMACEUTICALS AMERICA, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ADZYNMA", "application_number": "BLA125795", "marketing_category": "BLA", "marketing_start_date": "20231109", "listing_expiration_date": "20261231"}